Sermes CRO, a PSN compan in Spain attended the SETGYC Annual Congress

Sermes CRO, our PSN company in Spain, attended the 9th Congress of the SETYC – Spanish Society of cell and gen therapies

The Spanish Society for Gene and Cell Therapy (SETGyC) is a platform that aims to promote and support fundamental, translational and clinical research in these areas, as well as collaboration with institutions, biotechnological and pharmaceutical companies for development of new therapies. The complexity of these studies often requires a multidisciplinary approach and our Society is an ideal forum to find colleagues with whom to share knowledge and procedures for the development of new, more effective and safe therapies as well as good practice in gene and cell therapy products and in the clinical application of these products. Many of the teams that have implemented clinical trials on advanced therapies are members of the SETGyC, which aims to facilitate the translation of fundamental research to medical applications complying with European regulations for cell therapy and gene therapy, to advise on these aspects and to defend the good practice in cell production and in clinical application of cellular products.

The main objectives of  the Congress were:

• To boost the profile of gene and cell therapy in Spain and internationally

• To facilitate communication and exchange of expertise and resources between professionals

• To provide advice and advocacy in all themes relating to new and existing gene and cell therapies


Sermes CRO, as a company focus on the development  of Advance Therapies (ATMPs) in different therapeutic areas, and also working with different companies and investigational groups at hospital level, submitted two posters showing their collaboration with one of the most important projects in cell therapy.

The posters are created from the project with Mesenchymal Stromal cells (MSCs) of the Hospital Puerta de Hierro and the Principal Investigator Dr. Jesús vaquero. This new therapy, offers a new treatment alternative for patients with complete and inclomplete SCI  in Chronic established Paraplegia.

Spain is one of the leading countries in Europe with regard to the number of sponsors of advanced therapy medicinal products (ATMPs), which are mainly not-for-profit institutions. It is also a leader in the number of ATMPs undergoing clinical development programs. Source: Maciulaitis et al. (2012). Molecular Therapy; 20, 479–482 Objectives of the SETGyC Situation in Spain Through its activities, the SETGyC hopes to support fundamental and translational research aimed at the advancement of gene and cell therapy in Spain by promoting the incorporation of the latest international developments in the field.

CAT monthly report of application procedures, guidelines and related documents on advanced therapies

The Committee for Advanced Therapies (CAT) held its 102nd CAT meeting on 14 – 16 March 2018.

The CAT Monthly Report includes statistical data on CAT scientific recommendations on Advanced Therapy Medicinal Product (ATMP) classification, certifications, initial evaluations, CAT contributions to Scientific Advice and Paediatric Investigation Plans, as well as variations, line extensions, renewals. Scientific recommendation on advanced therapy product classification Further to consultation with the European Commission, the CAT finalised 1 scientific recommendation on the classification of advanced therapy medicinal products.

The following product was classified as a tissue engineered product:

• Autologous expanded auricular chondrocytes, intended for surgical implantation for the repair of microtia. Organisational matters

• CAT adopted the public report on the expert meeting on adeno-associated viral vector-based gene therapy medicinal product, which was held at the EMA on 6 September 2017. The report will be published shortly.

• CAT adopted the Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. The guideline, which is a revision of the guideline on genetically modified cells published in April 2012, will be released for public consultation by June 2018.

• CAT discussed the programme of the joint CHMP/PDCO/CAT Strategic Review and Learning meeting that will take place in Oslo, Norway on 7 – 9 May 2018 under the auspices of the Bulgarian presidency of the European Union.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

 Six medicines recommended for approval, including one orphan

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine1, at its March 2018 meeting.

  • The CHMP recommended granting a conditional marketing authorisation for Rubraca(rucaparib), for the treatment of relapsed or progressive ovarian cancer.
  • Juluca (dolutegravir / rilpivirine) received a positive opinion for the treatment of human immunodeficiency virus (HIV) infection.
  • Biosimilars: Kanjinti (trastuzumab) for the treatment of breast and gastric cancer; and Zessly (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
  • Generics: received a positive opinion from the CHMPPemetrexed Krka(pemetrexed), for the treatment of malignant pleural mesothelioma and non-small cell lung cancer; and Prasugrel Mylan (prasugrel), for the prevention of atherothrombotic events.


Negative opinions on two new medicines

  • Dexxience (betrixaban). Dexxience was expected to be used for the prevention of venous thromboembolism.
  • The Committee also adopted a negative opinion for Eladynos (abaloparatide). Eladynos was intended to be used to treat osteoporosis.


Three recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for CabometyxIvemend and Repatha.

Start of re-examination of recommendation on extension of therapeutic indication

The applicant for Sutent (sunitinib) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the February 2018 meeting. 

Start of referral: omega-3 fatty acid medicines

The CHMP started a review of the use of omega-3 fatty acid medicines in patients who have had a heart attack, following research showing that these oral products may not prevent recurrence of heart disease or stroke.





The EMA publishes a Q&A document on Rare Riseases


In support of Rare Disease Day, the EMA has published a question-and-answer document addressing common misunderstandings about the meaning of orphan designation and other aspects pertaining to orphan medicines.

This document explains key concepts in the regulation of medicines for rare diseases such as orphan designation and significant benefit. The Q&A document is available by clicking here.

For more information about orphan designation please click here.

Patients interested in working with the European Medicines Agency

The European Medicine Agency, as part of their endeavours to involve patients in all aspects of medicines evaluation and regulatory processes,  wants to share  the linked image  along with the message that any patients interested in working with the European Medicines Agency can register their interest and further share this link


Questions and answers – EMA individual experts’ stakeholder database: patients and consumers are also available.

New Videos Available on why EMA matters to European citizens

The European Medicines Agency (EMA) has published three video animations to explain how it ensures that medicines are effective and safe for citizens across the European Economic Area (EEA).

  • The first video explains that the Agency assesses, supervises and monitors medicines long before they appear in pharmacies and hospitals, and the whole time they are on the market, by bringing together the expertise from the European network.
  • The second animation describes the journey of a medicine from initial laboratory tests to its authorisation by EMA and the European Commission.
  • Finally, the third video focuses on how the Agency collects information on side effects from new clinical studies, scientific publications and reports from doctors, pharmacists and patients to keep medicines safe.

The videos are available on EMA’s website and on the official EMA YouTube channel.


Strengthened guidance on follow-up and risk management for ATMP developers

The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal products (ATMPs) for a three-month public consultation. The revision is part of the joint action plan published by the European Commission and EMA in October 2017 to streamline procedures and better address the specific requirements of ATMP developers.

This guideline replaces ‘Guideline on safety and efficacy follow-up – risk management of Advanced 10 Therapy Medicinal Products’ (EMEA/149995/2008)

This is the first revision of the ATMP guideline and focuses on safety and efficacy follow-up and risk management. The guideline now takes into consideration the experience gained with the authorisation of these medicines, as well as the experience with scientific advice and protocol assistance.

It also provides advice on early detection of risks during development and provides a framework for the effective mitigation of their consequences for patients. In addition, the revision gives methodological advice on the design of appropriate post-authorisation studies to follow up on the safety and efficacy of these medicines.

Please to see the full guide, click the link below:

ATMPs Guide reviwed2018

PSNResearch Proud to have Supported MND Association International Symposium

PSNResearch was Silver Sponsor of the 27th International Symposium on ALS/MND being run by the Motor Neurone Disease Association.


The Symposium is the world’s largest medical and scientific conference solely about Motor Neurone Disease / ALS. The 27th International Symposium on ALS/MND held in Boston, USA on 8 – 10 December 2017, over 1,200 delegates attended to hear about progress in research on a number of topics including pre-approval access, telemedicine, emerging markers, and cognitive change.


An overview of the EU’s orphan designation programme

The Agency is responsible for reviewing applications from sponsors for orphan designation. To qualify for orphan designation, a medicine must meet a number of criteria:

  • It must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
  • The prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development;
  • No satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorised, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

The EU’s orphan designation programme was launched in the year 2000 to encourage companies to research and develop medicines for rare diseases.

To date, over 1,900 medicines have been designated as orphan medicines, giving access to specific incentives that make it more attractive for companies to develop them. By the end of 2017 over 140 of these medicines were on the market, providing treatment options for patients who previously often had none.

The new factsheet published by European Medicines Agency today explains what a rare disease is, how the EU programme works and what incentives are made available to developers.

FDA clears stereotactic radiotherapy system for use in treating breast cancer

Radiation therapy is an important treatment option for cancer patients.

Approximately 60 percent of all cancer patients will be treated with some form of radiation therapy. During radiation therapy, tumor cells are killed when their DNA is damaged by the radiation being absorbed into them. While radiation therapy has the potential to kill tumor cells, it can also damage healthy tissue around the tumor.

The GammaPod system is intended for use in the non-invasive stereotactic delivery of a radiation dose to a portion (partial volume) of the breast in conjunction with breast conserving treatment. During the procedure, radiation is delivered to specific areas of the breast. The GammaPod has not been shown to be as effective as whole breast radiation therapy (WBRT) and is not intended to replace WBRT.

The GammaPod system is a dedicated stereotactic radiation therapy technology designed to treat breast cancer. GammaPod uses thousands of focused beams of radiation from 36 rotating radioactive Cobalt-60 sources in combination with a two-layer, vacuum-assisted cup that immobilizes the breast to achieve a more accurate delivery of radiation. The GammaPod design to immobilize the breast during treatment provides the benefit of minimizing the radiation dose to the surrounding healthy tissues in the breast, heart and lungs.

The FDA reviewed scientific evidence including a clinical study of 17 patients that tested the feasibility of accurately delivering the prescribed dose to the breast tumor while minimizing radiation to the healthy tissue. The clinical evidence supports delivering the prescribed dose to the breast tumor with minimal radiation-induced side effects such as skin redness or erythema.